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Merck & Co., Inc. (MRK - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending an approval for the label expansion of its blockbuster PD-1 inhibitor, Keytruda (pembrolizumab). The company is seeking a nod for Keytruda in combination with chemotherapy or the first-line treatment of adult patients with metastatic squamous non-small cell lung cancer (NSCLC) — a difficult to treat lung cancer population — regardless of PD-L1 expression.

Following CHMP’s favorable response, a decision in the EU is expected during the first quarter of 2019. On approval, this Keytruda combo will be the first anti-PD-1 therapy to be approved in the EU for adult patients afflicted with metastatic squamous NSCLC.

The affirmative CHMP feedback was based on data from the phase III KEYNOTE-407 study. Outcomes from the same showed that the combination of Keytruda plus chemotherapy led to a significant improvement in both overall survival (OS) and progression-free survival rates as compared to patients receiving only chemotherapy. Results presented from this study stole the limelight at the annual meeting of the American Society of Clinical Oncology last June.

In the United States, a similar label expansion was approved last October. This nod will help Merck gain access to a broader patient population and boost sales for its blockbuster drug.

Shares of Merck have surged 36.3% in the past year, outperforming the industry’s increase of 7.2%.

Keytruda is already approved for many types of cancers and treatment settings including lung cancer, melanoma, head and neck cancer, classical Hodgkin’s lymphoma and bladder cancer.

In a very short span of time, Keytruda has become the largest product in Merck’s portfolio. The drug generated sales of $7.17 billion in 2018, reflecting a massive increase of 88% year over year. Sales were driven by the launch of new indications globally. Keytruda sales are particularly gaining from a strong momentum in first-line lung cancer indication as it is the only anti-PD-1 medicine approved in first-line setting.

H Lundbeck’s earnings estimates have moved 5.2% north for 2019 over the past 60 days.

Novo Nordisk’s earnings estimates have been revised 1.9% upward for 2019 over the past 60 days.

Eli Lilly’s earnings estimates have been raised 1.4% for 2019 over the past 60 days. The stock has soared 55.1% in a year.

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